scholarly journals Proactive versus Reactive Therapeutic Drug Monitoring: Why, When, and How?

2021 ◽  
pp. 1-9
Author(s):  
Manar Shmais ◽  
Miguel Regueiro ◽  
Jana G. Hashash
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Loss Of Response ◽  
Inflammatory Bowel ◽  
Necrosis Factor

<b><i>Background:</i></b> Up to a third of inflammatory bowel disease) patients show primary nonresponse to antitumor necrosis factor (anti-TNF) biological therapy, and of those who respond, up to 40% develop secondary loss of response (LOR). Therapeutic drug monitoring (TDM) plays a crucial role in assessing patients with LOR to guide therapy by giving more of the drug or switching to a different biological agent. Although reactive TDM is suggested or recommended by the majority of gastroenterology associations, proactive TDM seems to be more controversial. <b><i>Summary:</i></b> In this article, we discuss the updated guidelines on TDM and will also discuss the available data supporting proactive and reactive TDM in patients with Crohn’s disease and those with ulcerative colitis using the different available biological agents. <b><i>Key Messages:</i></b> Therapeutic drug monitoring (TDM) is a valuable tool to aid in inflammatory bowel disease (IBD) therapy optimization. Reactive TDM is widely accepted in IBD patients with suspected loss of response, especially in those receiving antitumor necrosis factor (anti-TNF) agents. Proactive TDM is emerging as a reasonable approach to patients initiated on anti-TNF therapy, specifically infliximab and, to some extent, adalimumab, particularly for patients with severe ulcerative colitis and fistulizing Crohn’s disease. Similarly, TDM may play a role in patients considering de-escalation from combination therapy. To date, proactive TDM is not widely applied to ustekinumab and vedolizumab and more data are required before this becomes part of clinical practice.

The cost of treating inflammatory bowel disease: step-up vs step-down, therapeutic drug monitoring and personalised medicine

2021 ◽  
Vol 19 (4) ◽  
pp. 18-24
Author(s):  
Pearl Avery
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Personalised Medicine ◽  
Therapeutic Drug ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Step Down

Inflammatory bowel disease (IBD) is a group of lifelong immune-mediated diseases, including Crohn's disease and ulcerative colitis. IBD is traditionally treated with drugs, including 5-aminosalicylates, steroids and immunosuppressants. However, the treatment landscape is changing, owing to a number of factors of significance to the IBD clinical nurse specialist. The recent introduction of novel biologic and biosimilar medications has affected the efficacy and cost of treatment. The established step-up treatment paradigm, where patients are started on simpler, cheaper therapies, is shifting toward a step-down approach, where biologics are the first-line treatment. Meanwhile, nurse-led pro-active therapeutic drug monitoring, including patient-reported outcome measures (PROMs), is helping ensure the efficacy and safety of treatment and allows for adjustments. In the near future, personalised medicine may offer genetic testing to predict a patient's reaction to different drugs and identify the most appropriate therapies. At the author's hospital, some of these factors may have contributed to a 50% reduction in emergency surgical rates for ulcerative colitis. This clinical review examines these issues in light of real-world experience from the author's hospital.

Therapeutic drug monitoring of adalimumab in inflammatory bowel disease in children

2021 ◽  
Vol 19 (3) ◽  
pp. 14-25
Author(s):  
A.S. Illarionov ◽  
◽  
T.V. Radygina ◽  
A.S. Potapov ◽  
A.P. Fisenko ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Tumor Necrosis ◽  
Therapeutic Drug ◽  
Endoscopic Remission ◽  
Inflammatory Bowel ◽  
Factor Α ◽  
Necrosis Factor

Objective. To evaluate the significance of therapeutic drug monitoring of adalimumab (ADA) concentration levels and antibodies to it in inflammatory bowel disease (IBD) in children. Patients and methods. In this study, 103 children with IBD (24 patients with ulcerative colitis (UC) and 79 with Crohn’s disease (CD)) aged 3–18 years were examined during maintenance therapy with ADA (100 mg/mL in 0.4 mL). Body weight, duration of disease and therapy, use of azathioprine (AZA), achievement of clinical and endoscopic remission, albumin levels, residual levels of ADA and antibodies to the drug, circulating cytokine levels in serum were assessed. Results. A significant decrease in ADA levels in children in the absence of clinical remission in CD (5.21 [3.32; 7.43] μg/mL in remission) and in UC (2.42 [0.42; 4.51] μg/mL, p = 0.001) was shown. A high-quality separation model for residual ADA levels for exacerbation/remission conditions for clinical and endoscopic activity for children with CD and UC was obtained through ROC-analysis. The minimum residual ADA levels for maintaining clinical remission in children with CD were 8.1 μg/mL and 10.5 μg/mL for mucosal healing. In children with UC, as well as in children weighing <40 kg, these levels were higher. The formation of antibodies to ADA was minimal; combination therapy with AZA showed no efficacy. Key cytokines correlating with ADA concentration were interleukins IL-6, -13, -31, -27, -9, and tumor necrosis factor-α. Conclusion. To improve the efficacy of ADA therapy in children with IBD, therapeutic drug monitoring should be performed, considering the nosology and body weight of the child, as well as the goal of therapy (clinical and endoscopic remission). Key words: inflammatory bowel disease, Crohn’s disease, ulcerative colitis, adalimumab, therapeutic drug monitoring, tumor necrosis factor-α, cytokine profile, azathioprine

scholarly journals The Utility of Infliximab Therapeutic Drug Monitoring among Patients with Inflammatory Bowel Disease and Concerns for Loss of Response: A Retrospective Analysis of a Real-World Experience

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Robert A. Mitchell ◽  
Constantin Shuster ◽  
Neal Shahidi ◽  
Cherry Galorport ◽  
Mari L. DeMarco ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Statistical Significance ◽  
Therapeutic Drug ◽  
Loss Of Response ◽  
Remission Rates ◽  
Inflammatory Bowel ◽  
Group 3

Background. Infliximab (IFX) therapeutic drug monitoring (TDM) allows for objective decision making in patients with inflammatory bowel disease (IBD) and loss of response. Questions remain about whether IFX TDM improves outcomes. Methods. Patients with IBD who had IFX TDM due to concerns for loss of response were considered for inclusion. Serum IFX trough concentration and anti-drug antibody (ADA) concentrations were measured. Patients were grouped by TDM results: group 1, low IFX/high ADA; group 2, low IFX/low ADA; group 3, therapeutic IFX. Changes in management were analyzed according to groupings; remission rates were assessed at 6 months. Results. 71 patients were included of whom 37% underwent an appropriate change in therapy. Groups 1 (67%) and 2 (83%) had high adherence compared to only 9% in group 3. At 6 months, 57% had achieved remission. More patients who underwent an appropriate change in therapy achieved remission, though this did not reach statistical significance (69% versus 49%; P=0.098). Conclusions. A trend towards increased remission rates was associated with appropriate changes in management following TDM results. Many patients with therapeutic IFX concentrations did not undergo an appropriate change in management, potentially reflecting a lack of available out-of-class options at the time of TDM or due to uncertainty of the meaning of the reported therapeutic range.

scholarly journals Update on TDM (Therapeutic Drug Monitoring) with Ustekinumab, Vedolizumab and Tofacitinib in Inflammatory Bowel Disease

2021 ◽  
Vol 10 (6) ◽  
pp. 1242
Author(s):  
Sophie Restellini ◽  
Waqqas Afif
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Small Molecules ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Biologic Treatment ◽  
Improved Outcomes ◽  
Inflammatory Bowel ◽  
Necrosis Factor

The goal of therapeutic drug monitoring (TDM) is to optimize anti-TNF (tumor necrosis factor) biologic treatment in patients with inflammatory bowel disease (IBD). Although commercial assays are readily available for both ustekinumab and vedolizumab, the use of TDM with these newer biologic medications is at its infancy. The clinical utility of TDM with non-anti-TNF mechanisms of action is not clear. This review summarizes the latest available data on the pharmacokinetics of newer biologic and oral small molecules and highlights the threshold concentrations that have been associated with improved outcomes in IBD patients.

scholarly journals Role of therapeutic drug monitoring of azathioprine and thiopurine methyltransferase enzyme status in patients with inflammatory bowel disease: Indian scenario

2020 ◽  
Vol 9 (10) ◽  
pp. 1618
Author(s):  
Maninder Singh ◽  
Sandeep Kaushal ◽  
Kanchan Gupta ◽  
Ajit Sood
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Anal Verge ◽  
Current Status ◽  
Therapeutic Drug ◽  
Chron's Disease ◽  
Inflammatory Bowel

Inflammatory bowel disease is mainly caused by dysragulated immune system. Inflammatory bowel disease incidences are rising in Asian countries with difficulty in their diagnosis and managements. There is rising the incidences and prevalence rate in India. Inflammatory bowel disease has two major subtypes Ulcerative colitis and chron’s disease. In ulcerative colitis inflammation occurs in lower part of large intestine that extend from anal verge to proximal colon while in case of chron’s disease there is transmural inflammation of gastrointestinal tract. This review is to provide comprehensive review focused on the current status of therapeutic drug monitoring of azathioprine metabolites in patients of inflammatory bowel disease.

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